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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) (K142570)Ever Light Plastic Products Co., Ltd.2014-12-18
Nitrile Powder Free Examination Glove (Blue) (K142588)Hartalega Sdn Bhd2014-12-18
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (K143307)Rayner Intraocular Lenses , Ltd.2014-12-18
Powder Free Vinyl Patient Examination Gloves (K142571)Ever Light Plastic Products Co., Ltd.2014-12-17
GEN_3 (K141691)Free Wheelchair Mission2014-12-17
SOFIA (R) STREP A+ FIA (K141775)Quidel Corporation2014-12-16
Elecsys Estradiol III Calcheck (K143284)Roche Diagnostics2014-12-16
AIA-PACK C-Peptide Control Set (K143296)Tosoh Bioscience, Inc.2014-12-16
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141303)Zhida Glove Co., Ltd.2014-12-12
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141304)Yongxin Healthcare Co., Ltd.2014-12-12
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) (K142343)Tangshan Hongyun Plastic Products Co., Ltd.2014-12-10
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810)Becton, Dickinson and Company2014-12-10
TOTAL PROTEIN URINE/CSF GEN.3 (K141925)Roche Diagnostics Operations (Rdo)2014-12-09
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (K140971)Randox Laboratories Limited2014-12-08
Vinyl Co-Polymer Powder Free Examination Gloves (K142409)Grand Work Plastic Products Co., Ltd.2014-12-05
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (K143194)Siemens Healthcare Diagnostics, Inc.2014-12-05
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES (K141613)Zibo Goldenline Plastic Product Co., Ltd.2014-12-04
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR (K141287)Huikang Glove Co., Ltd.2014-12-03
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141279)Wanghui Glove Co., Ltd.2014-12-03
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE (K142270)Hartalega Sdb. Bhd.2014-11-25
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (K143026)Aalto Scientific, Ltd.2014-11-21
Audit MicroControls Linearity LQ Special Diabetes (K142978)Aalto Scientific, Ltd.2014-11-20
Sentinella 102; Sentinella 102 Horus (K143156)General Equipment For Medical Imaging (Oncovision-2014-11-18
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT (K140717)Siemens Healthcare Diagnostics2014-11-17
CL DETECT RAPID TEST (K141341)InBios International, Inc.2014-11-14
DRAEGER JAUNDICE METER JM-105 (K133175)Draeger Medical Systems, Inc.2014-11-13
ABL90 FLEX (K132691)Radiometer Medical Aps2014-11-13
LEAF PATIENT MONITORING SYSTEM (K141877)Leaf Healthcare, Inc.2014-11-10
YEESCOPE LARYNGOSCOPES (K140951)Yeescope Pty. , Ltd.2014-11-10
YONGFA (K140246)Yongfa Glove Co., Ltd.2014-11-06
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM (K140355)Terang Nusa Sdn Bhd2014-11-06
YONGHE (K140244)Yonghe Plastic Products Co., Ltd.2014-11-06
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (K142878)Siemens Healthcare Diagnostics, Inc.2014-10-30
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) (K142864)Siemens Healthcare Diagnostics, Inc.2014-10-29
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) (K142811)Siemens Healthcare Diagnostics, Inc.2014-10-29
LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR (K141221)Lares Research, Inc.2014-10-28
#8C RENEGADE DENTAL HANDPIECE (K142063)Handpiece Club, LLC2014-10-28
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES (K133069)Codent Technical Industry Co., Ltd.2014-10-24
HEMOPORE (K141816)Polyganics B.V.,2014-10-23
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE (K141125)Handpiece Headquarters2014-10-23
XprESS Multi-Sinus Dilation Tool (K142252)Entellus Medical, Inc.2014-10-17
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (K141579)Eco Medi Glove Sdn. Bhd.2014-10-17
ELEVATION (K140023)Pdg Product Design Group, Inc.2014-10-16
OSTOM-I ALERT (K140938)11 Health and Technologies, LLC2014-10-10
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM (K141623)Eco Medi Glove Sdn. Bhd.2014-10-07
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K141510)Eco Medi Glove Sdn. Bhd.2014-10-07
NOVASHIELD INJECTABLE NASAL PACKING AND STENT (K141704)Medtronic, Inc.2014-10-06
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE (K130450)Purna Bina Sdn Bhd2014-09-30
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (K140097)Applied Medical Technology, Inc.2014-09-24
ENDO SMART (K133298)Meta Biomed, Inc.2014-09-19
TREKKER, TREKKER TRANSIT (K140416)Convaid Products, Inc.2014-09-17
YUSHENG (K141108)Zibo Yusheng Plastic Products Co., Ltd.2014-09-16
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT (K141018)Procter & Gamble Co.2014-09-15
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE (K140050)Hartalega Sdn Bhd2014-09-12
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130742)Dahoon Plastic Co., Ltd.2014-09-10
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131340)Made Plastic Co., Ltd.2014-09-09
ELECSYS ESTRADIOL III CALCHECK 5 (K142127)Roche Diagnostics2014-09-05
AJAX DENTAL UNIT (K132245)Pro Dental Services, LLC2014-09-05
BIOGEL PL MICRO SURGICAL GLOVE (K141719)Molnlycke Health Care Us, LLC2014-09-04
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (K141590)Eco Medi Glove Sdn. Bhd.2014-09-03
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K140418)Wrp Rubber Products Sdn Bhd2014-09-03
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED (K142080)Ecolab, Inc.2014-08-28
LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES (K141239)Zibo Litong Plastic Products Co., Ltd.2014-08-27
AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K141307)Shijiazhuang Aok Plastic Co., Ltd.2014-08-27
RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K141305)Shijiazhuang Richful Plastic Co., Ltd.2014-08-27
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR (K141021)Hl Rubber Industries Sdn Bhd2014-08-26
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE (DEN140016)Dexcom, Inc.2014-08-19
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL (K141772)Siemens Healthcare Diagnostics, Inc.2014-08-19
MASTERSURG / EXPERTSURG (K140308)Kaltenbach & Voigt GmbH2014-08-15
BUZZY (K130631)Mmj Labs, LLC2014-08-13
POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) (K140988)Hebei Hongsen Plastics Technology Co, Ltd.2014-08-12
BLUE NITRILE POWDER FREE EXAM GLOVES (K133325)Shandong Xinshi Medical Products Co., Ltd.2014-08-08
NASOPORE-FD (K141423)Polyganics B.V.,2014-08-07
PATHASSIST LED LIGHT FIBER (K141916)Entellus Medical, Inc.2014-08-07
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (K131384)Kericure, Inc.2014-08-07
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K133168)Wrp Asia Pacific Sdn. Bhd.2014-08-07
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) (K140890)Hartalega NGC Sdn. Bhd.2014-07-24
COLONGLIDE LUBRICANT (K141028)Pediatric Pharmaceuticals, Inc.2014-07-24
DYNAMIC NEUROSCREENING DEVICE (K141208)Prosenex2014-07-23
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES (K133699)Pt. Smartglove Indonesia2014-07-18
ABX PENTRA MICRO ALB CONTROL L/H (K133676)HORIBA ABX SAS2014-07-11
EXAMINATION GLOVES (K140316)Hl Rubber Industries Sdn Bhd2014-07-11
MARATHON NO STING LIQUID SKIN PROTECTANT (K133443)Advanced Medical Solutions (Plymouth), Ltd.2014-07-10
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL (K141444)Siemens Healthcare Diagnostics, Inc.2014-07-09
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K140816)Better Care Plastic Technology Co., Ltd.2014-07-08
BENDA WEDGE (K140144)Centrix, Inc.2014-07-08
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL (K132778)Praxair Healthcare Services2014-07-07
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK (K133689)Pt. Medisafe Technologies2014-07-03
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM (K140685)Sybron Endo2014-07-02
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE (K132354)Advanced Health Products, Lot 60 & 612014-06-30
SHUNTONG (K140243)Shuntong Glove Co., Ltd.2014-06-30
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (K140542)Rhinosystems, Inc.2014-06-27
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL (K133816)Siemens Healthcare Diagnostics, Inc.2014-06-24
LIQUICHEK TUMOR MARKER CONTROL (K141073)Bio-Rad Laboratories2014-06-23
RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K133193)Riverstone Resources Sdn Bhd2014-06-23
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) (K140610)Hartalega NGC Sdn. Bhd.2014-06-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130733)Benteng Plastic Co., Ltd.2014-06-18
ARTHROCARE NASASTENT CMC NASAL DRESSING (K140992)ArthroCare Corporation2014-06-16
ZHAOFENG (K140240)Zhaofeng Glove Co., Ltd.2014-06-12
WHITE VINYL EXAM GLOVES POWDER FREE (K140322)Shandong Dawei Medical Products Co., Ltd.2014-06-12
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Every clearance here is in the API, with alerts when new ones post.